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The Problem of Colorectal Anastomosis Safety (ANSCRS)

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ClinicalTrials.gov Identifier: NCT03958500
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
Vilnius University hospital Santaros klinikos, Vilnius, Lithuania
National Cancer Institute, Lithuania
Information provided by (Responsible Party):
Marius Kryzauskas, Vilnius University

Brief Summary:
This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Carcinoma Colorectal Neoplasms Colorectal Adenocarcinoma Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Comprehensive anastomotic testing

All patients undergo:

  1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally
  2. Air leak test
  3. Methylene blue test
Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally
The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
Other Names:
  • Air leak test
  • Methylene blue test




Primary Outcome Measures :
  1. Rate of anastomotic leakage [ Time Frame: 0 to 60 days ]
    The number of patients, who had clinical or radiological anastomotic leakage. Proctography will be performed 6-8 days and 4-6 weeks after the primary operation.


Secondary Outcome Measures :
  1. Quality of life before and after the operation [ Time Frame: 0 to 60 days ]
    Using low anterior resection syndrome score (the LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).

  2. Quality of life before and after the operation [ Time Frame: 0 to 60 days ]

    Using QLQ-C30 questionnaire. To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) before operation and 4-6 weeks after the operation.

    The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

    The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.


  3. Reoperation rate [ Time Frame: 0 to 60 days ]
    Patients, who needed re-interventions

  4. Intraoperative test leakage [ Time Frame: 0 to 600 minutes ]
    Leakage rate detected intraoperatively after anastomosis testing

  5. Time of anastomosis testing [ Time Frame: 0 to 600 minutes ]
    Time from the start of the anastomosis testing till the end

  6. Operation time [ Time Frame: 0 to 600 minutes ]
    Time from the start of the operation until the end of the operation

  7. 90 days mortality [ Time Frame: 0 to 90 days ]
    the mortality of the patients after the operation

  8. Timing of anastomosis leakage [ Time Frame: 0 to 60 days ]
    In days after surgery



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients over 18 year
  • signed written consent
  • a colorectal anastomosis lower 15 cm from anal verge
  • elective surgery

Exclusion Criteria:

  • allergy to indocyanine green dye
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958500


Contacts
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Contact: Marius Kyzauskas +37062214027 marius.kryzauskas@santa.lt
Contact: Tomas Poskus, prof. +37068678893 tomas.poskus@santa.lt

Locations
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Lithuania
National Cancer Institute, Vilnius, Lithuania Recruiting
Vilnius, Lithuania
Contact: Audrius Dulskas, PhD.    +37067520094    audrius.dulskas@nvi.lt   
Vilnius University hospital Santaros klinikos Recruiting
Vilnius, Lithuania
Contact: Tomas Poskus    +37068678893    tomas.poskus@santa.lt   
Sponsors and Collaborators
Vilnius University
Vilnius University hospital Santaros klinikos, Vilnius, Lithuania
National Cancer Institute, Lithuania
Investigators
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Principal Investigator: Eligijus Poskus, prof. Vilnius University, Vilnius, Lithuania

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Responsible Party: Marius Kryzauskas, Principal investigator, Vilnius University
ClinicalTrials.gov Identifier: NCT03958500     History of Changes
Other Study ID Numbers: 2019/3-1116-608
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action